FDA Guidance for Industry: Q2A Validation of Analytical Procedures
Title:
FDA Guidance for Industry: Q2A Validation of Analytical Procedures
Origin/Publisher:
Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm ; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073381.pdf
Document Type:
FDA Guideline for Industry
Content:
This guideline identifies the validation parameters needed for a variety of analytical methods. It also discusses the characteristics that must be considered during the validation